Category: Audit

5W2H of Process Audits: What You Should Know

We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits. Who? Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform. Quality auditors must be professional, ethical and objective. They …

On-Site: What’s a C-TPAT Security Audit?

I’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain. A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when …

ISO 13485:201X Preparation (Medical Device Audits)

ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, …

Top 3 Benefits of C-TPAT Audits

Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is and how it benefits and adds organizational value. What is it? “The U.S. Customs-Trade Partnership Against Terrorism initiative (C-TPAT) is a voluntary U.S. Customs and Border Protection program designed to improve border …

An Introduction to Auditing – The How & Why

We saw this video posted recently and thought it was such an excellent introduction to audits that we had to share. We’ve also written a few articles related to auditing: Preparing for an Audit Top 3 Factory Audit Components Social Accountability Audits  Sustainability Audits